(346 days)
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Not Found
No
The document describes a robotic surgical system that replicates and scales surgeon movements. There is no mention of AI, ML, or image processing for decision-making or automated tasks. The system appears to be a teleoperated robotic system with motion scaling.
Yes
Explanation: The device is intended for "soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques" on various areas of the body, which directly involves treatment or mitigation of a disease or condition. This falls under the definition of a therapeutic device.
No
The Symani Surgical System is intended for performing surgical procedures (manipulation, suturing, and ligation) rather than identifying or analyzing a disease or condition. Its function is to assist in the treatment aspect of healthcare, not diagnosis.
No
The device description clearly outlines multiple hardware components: a Console, a Cart with Macropositioner and Micromanipulators, and articulated Instruments. This is a robotic surgical system, not a software-only device.
Based on the provided information, the Symani® Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a robotic surgical system with instruments for manipulating tissue during surgery.
- Lack of In Vitro Testing: The performance studies describe bench testing, cadaver testing, animal testing (in vivo), and clinical testing (on patients). There is no mention of testing biological samples outside of the body, which is characteristic of IVD devices.
- No Analysis of Biological Samples: The system's function is to assist in surgical manipulation, not to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Symani® Surgical System does not fit this definition. It is a surgical instrument/system used during a medical procedure on a living patient.
N/A
Intended Use / Indications for Use
The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis. suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities.
The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.
Product codes (comma separated list FDA assigned to the subject device)
SAQ
Device Description
The Symani Surgical System is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
The surgeon manipulates the Master Controllers, which in turn drive the articulated (wristed) robotic Instruments at the operating table/site, replicating and scaling down the surgeon movements using a chosen scaling factor. Symani is used in combination with conventional surgical microscopes, either optical or digital.
Symani is composed of three main components (Figure 1):
- The Console, which is a reusable equipment and not sterile; .
- The Cart with Macropositioner and two Micromanipulators, which is a reusable equipment . and not sterile: and
- . Two articulated Instruments, which are single-use and terminally sterilized via ethylene oxide
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast, Extremities: small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in soft tissue.
Indicated Patient Age Range
Adults (>18 years old)
Intended User / Care Setting
Trained physicians in an appropriate operating environment; OR staff
Clinical Setting: Operating Room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical/Bench Studies
Performance tests demonstrating that the Symani Surgical System will perform as anticipated for its intended use and to mitigate the risks to health. Categories of testing include: Biocompatibility/Materials, Sterility/Reprocessing/Packaging/Shelf life, Electromagnetic Compatibility and Safety Testing, Wireless Technology, Software, Cybersecurity, Performance Testing – Bench.
Performance Testing - Cadaver and Simulated Use
Cadaver Testing:
Purpose: To verify system ergonomics and usability in a scenario simulating an operating room environment.
Methods: A cadaver lab was used to simulate several standard procedures widely used in reconstructive microsurgery (Transoral access, Facial artery access, Internal mammary artery access, Thoracodorsal artery access, Radial artery access, Brachial plexus access, and Lower limb access). Two robotic wristed Instruments (Dilator and Needle Holder) were used. Tests were performed by a team composed of two expert surgeons and six residents, with MMI Clinical Engineers providing guidance.
Parameters analyzed: Suitability of system architecture for each access, necessity of a microscope extension tube, potential interference of instruments with surrounding tissues, depth of instrument run sufficiency, suitability of instruments' angle with Macropositioner, suitability of angle between instruments' shafts.
Results: The Symani architecture allows users to reach all desired anatomical districts for robotically performing reconstructive microsurgical procedures. The design allows adequate range of configurations and direct manual access.
Simulated Use Testing:
Purpose: To assess the precision in stitch placement with the system compared to the same microsurgical tasks using manual instruments.
Methods: 20 experienced surgeons (>5 years of microsurgery practice) and 16 users with no microsurgery experience performed needle passage tasks both manually and robotically three times. The protocol replicated standard microsurgery training models (stitch placement and knot tying on latex patches and silicone tubes). Distances and angles of needle entrance and exit were measured with a digital microscope. Data analysis of needle passage parameters was conducted using a paired T-test.
Results: Use of Symani was associated with greater precision (smaller difference between right and left distances from the cut on latex tissue) compared to manual execution. This difference was greater for experienced microsurgeons (p = 0.02) than for users with no microsurgery experience (p = 0.36). Higher precision was shown for angular precision (entry/exit angles relative to vertical cut). Experienced microsurgeons performed better manually and robotically. Improvement in needle angulation was greater for users with no microsurgery experience (p
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR SYMANI SURGICAL SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Electromechanical system for open microsurgery. An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open microsurgical procedures using surgical instruments attached to an electromechanical arm.
NEW REGULATION NUMBER: 21 CFR 878.4963
CLASSIFICATION: Class II
PRODUCT CODE: SAQ
BACKGROUND
DEVICE NAME: Symani Surgical System
SUBMISSION NUMBER: DEN230032
DATE OF DE NOVO: April 25, 2023
SPONSOR INFORMATION:
MMI North America, Inc. 344 Ponte Vedra Blvd. Ponte Vedra, Florida 32082
INDICATIONS FOR USE
The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis. suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities.
The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.
LIMITATIONS
1
The sale, distribution, and use of the Symani Surgical System are restricted to prescription use in accordance with 21 CFR 801.109.
Safety and effectiveness of Symani Surgical System has not been established for replantation of the fingers, toes, or limbs.
Safety and effectiveness of Symani Surgical System has not been established for free-flap surgery of the head & neck and trunk.
Safety and effectiveness of Symani Surgical System has not been established in the heart, central circulatory system, central nervous system, peripheral nervous system, or the eye.
The long-term outcomes of lymphovenous anastomoses performed with the Symani System for the treatment of lymphedema have not been evaluated.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Symani Surgical System is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
The surgeon manipulates the Master Controllers, which in turn drive the articulated (wristed) robotic Instruments at the operating table/site, replicating and scaling down the surgeon movements using a chosen scaling factor. Symani is used in combination with conventional surgical microscopes, either optical or digital.
Symani is composed of three main components (Figure 1):
- The Console, which is a reusable equipment and not sterile; .
- The Cart with Macropositioner and two Micromanipulators, which is a reusable equipment . and not sterile: and
- . Two articulated Instruments, which are single-use and terminally sterilized via ethylene oxide
2
Image /page/2/Figure/0 description: The image shows a Symani surgical robot. The robot is white and has a robotic arm with multiple joints. The robot is on wheels, and there is a control panel next to it. The robot is designed to assist surgeons with minimally invasive surgery.
Figure 1: Main components of the Symani Surgical System (from left to right. Console, Cart with Macropositioner and two Micromanipulators, Instrument)
Symani System Components
Console
The Console (Figure 2) is the main user interface to control the Instruments while in teleoperation mode. It is composed of:
- An equipped Chair for surgeon ergonomic posture .
- . Two hand-held wired Master Controllers
- A Tracking System to detect Master Controllers' motion within a defined workspace .
- . A Footswitch for activating different operating modalities
Image /page/2/Picture/9 description: The image shows a white chair with armrests and footswitch pedals. The chair has a tracking system attached to it. The chair is on wheels and has a footrest. The footswitch pedals are blue and yellow.
Figure 2: Console
Cart, Macropositioner and Micromanipulators (CMM)
The CMM (Figure 3) primary function is to actuate two articulated Instruments replicating the surgeon's movements within the surgical workspace. It is composed of:
- · A Cart,
3
- · A Macropositioner,
- . Two Micromanipulators
Image /page/3/Figure/2 description: The image shows a medical device with several labeled components. The device includes a cart for mobility, a touch screen for user interface, and an LEDs bar. It also features a macropositioner and two micromanipulators, labeled as 1 and 2, which are likely used for precise movements during medical procedures.
Figure 3: Cart with Macropositioner and Micromanipulators
Instruments
The Instruments are single-use and are provided in sterile condition (EtO sterilized). The Instruments (Figure 4) are mechanically attached to the Micromanipulators before the surgical procedure. The attachment system allows replacement during the microsurgery procedure as needed, and removal at the end of procedure. There are 5 instruments (Table 1) and each Instrument is comprised of:
- . A backend, which incorporates transmission systems required to activate the Instrument articulated wrist and tips;
- . A rigid elongated hollow shaft, providing a connection between the distal articulated wrist and the backend;
- An articulated wrist with three degrees of freedom (DOFs) pitch, yaw, and grip; the wrist, . which is placed at the distal end of the shaft, is activated by tendons running through the hollow shaft.
Image /page/3/Picture/9 description: The image shows a surgical instrument with labels pointing to different parts. The labels indicate the backend, shaft, and wrist of the instrument. The wrist is shown in more detail in an inset image, highlighting the articulating joint and the grasping mechanism. The instrument appears to be designed for minimally invasive surgery, allowing for precise movements within the body.
Figure 4: Detailed views of Articulated Instruments
4
| Table 1: List of instruments | |||||
|---|---|---|---|---|---|
| Name | Reference Code | Selling Code | Intended Use Description | Articulated Wrist Diameter | Pictures |
| Micro Needle Holder | INS-AaT2221 | INS-M-NH | Tips optimized for grasping/handling microsurgical sutures ranging from 8-0 to 10-0 with needles ranging from 70 to 150μm | 3.5 mm | Image: Micro Needle Holder |
| Micro Needle Holder Suture Cut | INS-AeT1221 | INS-M-NHSC | Tips optimized for grasping/handling microsurgical sutures ranging from 8-0 to 10-0 with needles ranging from 70 to 150μm and cutting the associated suture threads | 3.5 mm | Image: Micro Needle Holder Suture Cut |
| Micro Dilator | INS-ObM1221 | INS-M-DIL | Instrument with optimized tips to dilate vessels with diameter above 0.7mm and grip to handle microsurgical sutures ranging from 8-0 to 10-0 | 3.5 mm | Image: Micro Dilator |
| Supermicr 0 Needle Holder | INS-NaS2221 | INS-SM-NH | Tips optimized for grasping/handling microsurgical sutures ranging from 10-0 to 12-0 with needles ranging from 50 to 100μm | 3.0 mm | Image: Supermicr 0 Needle Holder |
| Supermier o Dilator | INS-DbS1221 | INS-SM-DIL | Instrument with optimized tips to dilate vessels with diameter ranging 0.3 to 1.0mm and grip to handle microsurgical sutures ranging from 10-0 to 12-0 | 3.0 mm | Image: Supermier o Dilator |
De Novo Summary (DEN230032)
5
Symani Sterile Accessories
The Symani System includes several disposable accessories mainly intended to preserve the sterility of the operating field.
Connector
The Connector's (Figure 5) main function is to physically separate the sterile Instrument from the non-sterile Symani. The Connector is mounted on the Micromanipulator after the sterile drape is placed on the Symani, and provides the means to connect the Instrument, while preserving the sterile field.
Image /page/5/Figure/4 description: The image shows a person in a clean suit holding an instrument. The instrument is connected to a micromanipulator via a connector. The person is wearing blue gloves and a white clean suit. The image is likely taken in a cleanroom environment.
Figure 5: Connector mounted onto the Micromanipulator
Master Controller Clips
The Master Controller Clips are used to affix the Master Controller Drape to the Master Controller and to improve the ergonomics of the grasps to users (Figure 6).
Image /page/5/Picture/8 description: In the image, a pair of tweezers is being held by a hand wearing a glove. The tweezers are made of metal and have white handles. The tweezers are holding a small amount of white material. The background is a light blue color.
Figure 6: Master Controller Clip Assembled on the Master Controller and Master Controller Drape
Master Controller Holder
The Master Controller Holder's function is to stow the Master Controllers when not in use by the surgeon. The Master Controller Holder is composed by a cup with an elastic clip, which is used to affix the holder to the seat armrest (Figure ).
6
Pouches
As an alternative to the Master Controller Holder (Figure 7), Pouches with an adhesive strip can be used to support the draped Master Controllers when not used during the surgical operation to preserve their sterility. OR staff can choose to use sterile pouches instead of the Master Controller Holders based on their preference. Sterile pouches are manufactured by 3MIM and are commercially available in US.
Image /page/6/Figure/2 description: The image contains two photos. The photo on the left shows a chair with a master controller holder attached to it. The photo on the right shows a piece of medical equipment that is covered in plastic.
Figure 7: Master Controller Holder installed onto the Chair (left) and Pouch attached to the right side of the Console Drape (right)
Third-party Devices and Accessories
Drapes
The Symani Surgical System is intended to be used with third-party drapes (which are provided with the Symani Surgical System) as shown in Table 2. The sterile drapes are thin, flexible plastic covers, supplied in sterile conditions. The drapes separate the sterile Instruments and the sterile field from the non-sterile parts of the system. Three drapes are used to cover the Symani CMM (Robot Drape), the Console (Console Drape) and the Master Controllers (Master Drape).
| REF | Description | 510(k) # | Sterile | Disposable |
|---|---|---|---|---|
| DRP-100 | Chair Drape | K101689 | Yes | Yes |
| DRP-201 | Master Drape | K101689 | Yes | Yes |
| DRP-302 | Robot Drape | K101689 | Yes | Yes |
Table 2: Third-Party Devices Provided with the Symani Surgical System
Microscopes
The Symani Surgical System is compatible the optical surgical microscopes listed in Table 3.
7
| Table 3: Compatible 3rd-Party Microscopes | |
|---|---|
| Microscope | 510(k) # |
| Zeiss KINEVO 900 | Exempt |
| Zeiss OPMI VARIO with accessories | K162991 |
| Leica M525-F50 | Exempt |
| Storz VITOM | Exempt |
| True Digital Surgery OCCIPTA | Exempt |
| Olympus ORBEYE | K190772 |
SUMMARY OF NON-CLINICAL/BENCH STUDIES
Non-clinical performance tests were performed to demonstrate that the Symani Surgical System will perform as anticipated for its intended use and to mitigate the risks to health as outlined below.
BIOCOMPATIBILITY/MATERIALS
The purpose of testing all materials for biocompatibility and pyrogenicity is to mitigate the risk of adverse tissue reactions and infections for the patient.
The instruments are external communicating devices in contact with tissue/bone/dentin for limited duration (5 years of microsurgery practice) and 16 users with no microsurgery experience performed the needle passage task both manually and robotically for three times. The protocol replicates standard microsurgery training models, e.g., execution of basic microsurgery tasks (stitch placement and knot tying) on validated synthetic models (latex patches and silicone tubes). Distances and angles of needle entrance and exit with respect to the cut were measured through a digital microscope. Data analysis of needle passage parameters (distance and angle) has been conducted through a paired T-test, comparing the needle passage data of manual and robotic treatments for each user group.
Results
The use of Symani was associated with greater precision (smaller difference between the right and the left distances from the cut on latex tissue) compared to manual execution [1]. The paired Ttest showed that this difference in performance was greater for experienced microsurgeons (p = 0.02) than for users with no users with no microsurgery experience (p = 0.36). The results also
14
showed higher precision using Symani compared to the manual execution for angular precision (entry/exit angles relative to the vertical cut). Experienced microsurgeons had better performance on manual and robotic needle angulation than users with no microsurgery experience. This difference in performance was greater for users with no microsurgery experience (p 18
- 2. Patients who need a reconstructive procedure and a microsurgical reconstruction is deemed the best option by the plastic, orthopedic or other surgeon in response to a postoncological, post-traumatic or congenital tissue defect or to treat lymphedema.
-
- Patients who have been selected by the PI at the Clinical Center as appropriate candidates for treatment with Symani System in accordance with the IFU.
-
- Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps. replantation, lymphatic reconstructions.
-
- Subjects who agree to have the surgery and the anesthesia.
- Subjects who voluntarily decide to participate in this study with the surgery performed 6. with the aid of the Symani System and sign the Informed Consent Form.
Exclusion Criteria
Individuals were excluded from participating in the Symani study if any of the following criteria were met:
-
- Subiects who have bleeding or coagulation disorders in the past or present.
-
- Any criteria that preclude prolonged anesthesia.
-
- History of anaphylaxis or severe complicated allergy symptoms.
-
- Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the data collection or the ability to comply with the protocol.
-
- Evidence or history of autoimmune disease or compromised immune system.
-
- Participation in another clinical trial within 4 weeks prior to participation in the study.
-
- Subjects belonging to vulnerable populations or ineligible to participate for other reasons
17
by the PI at a Clinical Center.
-
- Subjects with pacemaker.
The patients selected for the retrospective data collection were those who met the Inclusion and Exclusion Criteria for Symani study whose microsurgical reconstructive procedures were performed prior to the study initiation at the site.
- Subjects with pacemaker.
Follow-up
Patients were enrolled, underwent surgery, and had assessments made at regular intervals (perioperatively, day 1, day 4, day 14, and day 30).
Free-Flap Surgery of Breast and Extremities
Sample Size
93 evaluable patients were included in the analysis.
Study Endpoints
The following endpoints were used for the granting descision based on the device's intended use.
Effectiveness endpoints include the following:
- Intraoperative anastomosis patency .
- . Robotic usage time
- . Rate of intra-operative approach changes from robotic to manual
Safety endpoints include the following:
- Freedom from device related serious adverse events prior to discharge .
- . Freedom from device-related adverse events through discharge.
- All adverse events, regardless of device relatedness, reported within 30 days post initial or . revision procedure.
- . Anastomosis-specific reoperation rate through 3 days
- All-cause readmission rates through 30 days .
- . All-cause mortality rate through 30 days
These other endpoints were evaluated but were not the basis the granting.
Effectiveness endpoints include the following:
- Free flap viability at discharge .
- Free flap survival at 30 days either after the first attempt or perioperative revision, for patients . with at least one robotic anastomosis.
- . Operative time
Safety endpoints include the following:
- All-cause reoperation rate through 30 days .
18
Free-flap survival at 30 days and all-cause reoperation rate through 30 days were compared to the UK National Flap registery. These endpoints, however, were not used for making the granting descision as many factors outside of creating the anastomosis contribute to the flap survival rate and reoperation rate at 30 daysFree-flap survival at 30 days and all-cause reoperation rate through 30 days were compared to the UK National Flap registery. These endpoints, however, were not used for making the granting descision as many factors outside of creating the anastomosis contribute to the flap survival rate and reoperation rate at 30 days.
Free-Flap Transfer Results
Table 6 summarizes the patient demographics for the clinical study for free-flap procedures. Table 7 reports the disposition of patients in Free-Flap procedures.
| Characteristic | Statistics | Breast | Extremities |
|---|---|---|---|
| Demographics | |||
| Age (years) | Mean (SD); N | 54.1 (10.6); 22/22 | 55.4 (17.5); 30/30 |
| Gender | - | - | - |
| Male | n (%); N | 0; 0/24 | 67.7; 21/31 |
| Female | n (%); N | 100; 24/24 | 32.3; 10/31 |
| Race | - | - | - |
| Caucasian | n (%); N | 100; 22/22 | 100; 28/28 |
| Black | n (%); N | 0; 0/22 | 0; 0/28 |
| Asian | n (%); N | 0; 0/22 | 0; 0/28 |
| Other | n (%); N | 0; 0/22 | 0; 0/28 |
| Height (cm) | Mean (SD); N | 0; 0/22 | 172.6 (9.7); 31/31 |
| Weight (kg) | Mean (SD); N | 167.0 (5.77); 22/22 | 81.4 (16.2); 31/31 |
| BMI | Mean (SD); N | 25.9 (4.0); 19/19 | 27.4 (5.2); 30/30 |
| Pre-operative co-existing conditions/disease | |||
| Pre-operative | |||
| radiotherapy | n (%); N | 70.8; 17/24 | 19.4; 3/31 |
| Pre-operative | |||
| chemotherapy | n (%); N | 75; 18/24 | 9.7; 3/31 |
| Smoking now/past | n (%); N | 40.9; 2/22 | 50; 15/30 |
| Hypertension | n (%); N | 25; 6/25 | 42; 13/31 |
| Pulmonary disease | n (%); N | 4.2; 1/24 | 3.2; 1/31 |
| Diabetes | n (%); N | 4.2; 1/24 | 19.4; 6/31 |
| Ischaemic heart disease | n (%); N | 4.2; 1/24 | 19.4; 6/31 |
| Alcohol consumption | |||
| over limits | n (%); N | 0; 0/23 | 0; 0/31 |
| Steroids | n (%); N | 0; 0/24 | 6.5; 2/31 |
Table 6: Free-Flap Clinical Study Demographics in the Breast and Extremities
19
| Characteristic | Statistics | Breast | Extremities |
|---|---|---|---|
| Extra-cardiac | |||
| arteriopathy | n (%); N | 0; 0/21 | 9.7; 3/31 |
| BMI | - | - | - |
| =23 days N=7 | N=5 | ||
| no follow-up at |
=23 days N=5 | N=2
no follow-up at
=23 days N=2 | 10
no follow-up at
=23 days N=8
Buried flap: n=2 | 9
no follow-up at
=23 days N=7
Buried flap: n=2 | N=1
no follow-up at
=23 days N=1 |
| Safety Set (SS) | Equivalent to FAS | Equivalent to FAS | Equivalent to
FAS | Equivalent to
FAS | Equivalent to
FAS | Equivalent to
FAS |
| Study completion
status | Completed: 18
Missing: 0
Withdrawn: 7 | Completed: 9
Missing: 0
Withdrawn: 4 | Completed: 9
Missing: 0
Withdrawn: 3 | Completed: 24
Missing: 0
Withdrawn: 7 | Completed: 17
Missing: 0
Withdrawn: 5 | Completed: 7
Missing: 0
Withdrawn: 2 |
Table 8: Summarizes the vessel diameter distribution for free flap surgery.
Table 8: Free Flap Vessel Diameter Distribution in the breast and Extremities
20
| Vessel
| Diameter | Breast | Extremities | ||
|---|---|---|---|---|
| Number of | ||||
| anastomoses | ||||
| (N=24) | Percentage | Number of | ||
| anastomoses | ||||
| (N=66) | Percentage | |||
| ≤ 0.5 mm | 0 | 0% | 0 | 0% |
| 0.6 - 1.0 mm | 2 | 8.3% | 15 | 22.7% |
| 1.1 - 1.5 mm | 3 | 12.5% | 23 | 34.8% |
| 1.6 - 2 mm | 5 | 20.8% | 12 | 18.2% |
| 2.1 - 2.5 mm | 9 | 37.5% | 8 | 12.1% |
| > 2.5 mm | 5 | 20.8% | 8 | 12.1% |
Effectiveness Results:
Intra-operative patency at first attempt is presented in Error! Reference source not found .. In these procedures if patency is not achieved on the first attempt the anastomosis is revised in the index procedure until patency is achieved.
| Site | Number of
anastomoses | Number
patent | Patency
estimate | 95% CI |
|-------------|--------------------------|------------------|---------------------|-----------------|
| Extremities | 44 | 40 | 90.9% | [78.3%, 97.5%] |
| Breast | 24 | 24 | 100% | [85.8%, 100.0%] |
Table 10: Intra-operative Anastomosis Patency at first attempt
Notes: All confidence intervals are constructed using exact methods in SAS PROC FREQ
The suturing time are shown in Table. The rate of intra-operative approach changes from robotic to manual is in Table 12. The outcome measure is based on the response to the Case Report Form question, "Did you experience any system technical issues resulting in unplanned return to conventional suturing." The subset of data used for this secondary effectiveness endpoint where the answer was "No" but the number of robotic sutures was missing, the dataset was excluded from the analysis. None of the device related issues that resulted in the user changing from robotic to manual resulted in revision of the anastomosis following the index procedure.
Table 11: Suturing time reported as mean (standard deviation) from the "all enrolled data set".
| | Number of
anastamoses | Anastomosis
procedure
time (mins) | Number of sutures/
anastamoses (n) | Average time per
suture (mins) |
|-----------------------------|--------------------------|-----------------------------------------|---------------------------------------|-----------------------------------|
| Breast | | | | |
| Only robotic
anastomoses | 8 | 25.0
(6.98) | 7.6 (0.52) | 3.28 (0.783) |
21
| | Number of
anastamoses | Anastomosis
procedure
time (mins) | Number of sutures/
anastamoses (n) | Average time per
suture (mins) |
|------------------------------------------------------|--------------------------|-----------------------------------------|-------------------------------------------|-----------------------------------------------|
| Hybrid: Both
robotic and
manual
anastomoses | 4 | 32.5 (14.53) | Robotic: 8.0 (0.82)
Manual: 1.8 (0.96) | Robotic: 3.27 (1.288)
Manual: 4.00 (2.449) |
| Only manual
anastomoses | 6 | 18.3
(4.41) | 8.3 (0.52) | 2.19 (0.499) |
| Extremities | | | | |
| Only robotic
anastomoses*# | 30 | 38.0
(11.61) | 8.5 (2.62) | 4.28 (1.320) |
| Hybrid: Both
robotic and
manual
anastomoses | 5 | 49.2 (12.50) | Robotic: 6.6 (3.36)
Manual: 4.8 (3.11) | Robotic: 6.20 (3.109)
Manual: 3.24 (1.714) |
| Only manual
anastomoses | 13 | 40.7 | 9.7 (2.36) | 4.02 (1.333) |
- Some of the manual sutures were not recorded so the "only robotic" group may not be all robotic anastomoses #Some robotic sutures were not recorded
Table 12: Intraoperative Approach Change for Free-Flap by Anatomical Site
| Site | Number of changes | Percentage |
|---|---|---|
| Upper/lower limbs | 4/36 | 11.1% |
| Breast | 1/13 | 7.7% |
Safety Results:
The 3-day anastomosis specific reoperation rate is a clinical risk to the anastomosis in free flap surgery (Table 13). This is the timeframe the anastomosis typically fails and needs a revision. In the extremities cohort there was one reoperation (1/31; 3.23%) done within 3 days to revise the anastomosis due to venous congestion. For this patient intraoperative patency was achieved on the first attempt.
Table 13: Reoperation Rates reported as mean percentage with the 95% confidence interval
| Site | 3-day Anastomosis specific Reoperation Rates |
|---|---|
| Extremities | 3.23% |
| [0.1%, 16.7%] | |
| Breast | 0% |
| [0.00%, 14.8%] |
*Kaplan-Meier (KM) product limit analysis was undertaken on this data.
There were 10 serious adverse events recorded in the clinical database which consisted of
22
hematoma, flap necrosis, and thrombosis (Table ). There were no serious device related adverse events. There was one non-serious device related adverse event resulting in tissue injury. This was related to the "Grip Release Mode" feature, which becomes available when teleoperation is interrupted while the Instrument tips are squeezed. The function allowed the user to open the instrument's tips before re-entering teleoperation. This feature that contributed to this injury was removed from the device. An additional analysis was conducted evaluating it the adverse event (i.e., thrombosis, necrosis) lead to revision of the anastomosis after the index procedure. There was no adverse events leading to revision of the anastomosis.
| Site | All Adverse
Events | Serious Adverse
Events | Device Related
Adverse Events | Device Related
Serious Adverse
Events |
|-------------|-----------------------|---------------------------|----------------------------------|---------------------------------------------|
| Extremities | 12.9%, 4/31 | 12.9%, 4/31 | 3.2%, 1/31 | 0%, 0/31 |
| Breast | 25%, 6/24 | 25%, 6/24 | 0%, 0/24 | 0%, 0/24 |
Table 14: Adverse Event Rates through 30 days
Other safety endpoints captured are shown in Table
Table 4: Other Safety Endpoints as mean percentage with the 95% confidence interval
| Safety Endpoints | Extremities | Breast |
|---|---|---|
| All-cause readmission rates through 30 | ||
| days* | 0.0% (0.0%, | |
| 0.0%) | 0.0% (0.0%, | |
| 0.0%) | ||
| All-cause mortality rate through 30 days* | 0.0% (0.0%, | |
| 0.0%) | 0.0% (0.0%, | |
| 0.0%) |
*Kaplan-Meier Kaplan-Meier (KM) product limit analysis was undertaken on this data
Lymphatic Surgery in Lymphedema
Lymphatic Surgery Results
Sample Size
70 evaluable patients were included in the analysis.
Study Endpoints
The following endpoints were used for the granting decision based on the device's intended use.
Effectiveness endpoints include the following:
- Intraoperative anastomosis patency .
- Robotic usage time .
- . Rate of intra-operative approach changes from robotic to manual
Safety endpoints include the following:
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- . Freedom from device related serious adverse events prior to discharge
- . Freedom from device-related adverse events through discharge.
- . All adverse events, regardless of device relatedness, reported within 30 days post initial or revision procedure.
- All-cause reoperation rate through 30 days .
- . All-cause readmission rates through 30 days
- All-cause mortality rate through 30 days .
Table 16 summarizes the patient demographics for the clinical study for lymphatic surgery. Table 17 reports the disposition of patients in lymphatic surgery. The data is divided into upper and lower extremities due to success rates largely depending on anatomical location in lymphatic surgery.
| Characteristic | Statistics | Upper
Extremities | Lower
Extremities |
|------------------------------------|--------------|----------------------------------------------|----------------------|
| | Demographics | | |
| Age (years) | Mean (SD); N | 54.3 (10.9); 35/35 | 48.7 (13.1); 38/3 |
| Gender | | | |
| Male | n (%); N | 5.7; 2/35 | 28.9; 11/38 |
| Female | n (%); N | 94.3; 33/35 | 71.1; 27/38 |
| Race | | | |
| Caucasian | n (%); N | 97.1; 34/35 | 86.8; 33/38 |
| Black | n (%); N | 0.0; 0/35 | 14.3; 5/35 |
| Asian | n (%); N | 0.0; 0/35 | 0.0; 0/38 |
| Other | n (%); N | 2.9; 1/35 | 0.0; 0/38 |
| Height (cm) | Mean (SD); N | 163.7 (7.8); 35/35 | 169.4 (9.0); 38/3 |
| Weight (kg) | Mean (SD); N | 67.4 (13.1); 35/35 | 75.0 (16.3); 38/3 |
| BMI | Mean (SD); N | 25.2 (4.5); 35/35 | 26.1 (5.4); 38/38 |
| | | Pre-operative co-existing conditions/disease | |
| Pre-operative
radiotherapy | n (%); N | 45.7; 16/35 | 13.2; 5/38 |
| Pre-operative
chemotherapy | n (%); N | 62.9; 22/35 | 7.9; 3/38 |
| Smoking now/past | n (%); N | 31.4; 11/35 | 29.7; 11/37 |
| Hypertension | n (%); N | 20.0; 7/35 | 28.9; 11/38 |
| Pulmonary disease | n (%); N | 11.4; 4/35 | 7.9; 3/38 |
| Diabetes | n (%); N | 2.9; 1/35 | 2.6; 1/38 |
| Ischaemic heart disease | n (%); N | 0.0; 0/35 | 0.0; 0/38 |
| Alcohol consumption
over limits | n (%); N | 8.6; 3/35 | 0.0; 0/37 |
| Steroids | n (%); N | 5.7; 2/35 | 5.3; 2/38 |
Table 16: LVA Clinical Study Demographics
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| Characteristic | Statistics | Upper
Extremities | Lower
Extremities |
|-------------------------------|------------|----------------------|----------------------|
| Extra-cardiac
arteriopathy | n (%); N | 2.9; 1/35 | 0.0; 0/38 |
| BMI | - | - | - |
| In vivo performance testing
Labeling |
| Tissue injury Reoperation Thrombosis Flap failure Necrosis Hematoma | In vivo performance testing
Postmarket surveillance
Training
Human factors testing
Labeling
Annual reporting |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the electromechanical system for open microsurgery is subject to the following special controls:
- (1) Data obtained from premarket in vivo performance validation testing and postmarket data acquired under anticipated conditions of use must demonstrate that the device performs as intended in the intended patient population and anatomical location, unless FDA determines based on the totality of the information provided for premarket review that data from postmarket surveillance is not required. Objective performance measures (e.g., patency and rate of device related adverse events and their severity, cause, and outcomes) for the device and a clinically justified comparator must be reported with relevant descriptive or developmental performance measures
- (2) The device manufacturer must develop. and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical techniques, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
- (3) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
- (4) Labeling must include:
- A detailed summary of in vivo performance testing conducted with the device. (i) including study population, results, adverse events, and comparisons to any comparator groups identified:
- (ii) A statement in the labeling that the safety and effectiveness of the device has not been evaluated for outcomes related to the treatment or prevention of cancer, including but not limited to risk reduction, overall survival, disease-free survival and local recurrence, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
- Identification of compatible devices; (iii)
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- (iv) Reprocessing instructions for reusable components;
- Use life for reusable components; (v)
- (vi) Shelf life for any sterile components;
- (vii) A description of the device-specific use training program;
- (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
- (ix) A detailed summary of the postmarket surveillance data collected under paragraph (1) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the postmarket data collected under paragraph (1) of this section.
- Human factors validation testing must be performed and must demonstrate that the (5) device/user interfaces of the system support safe use in all use environments.
- (6) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
- Device motion accuracy and repeatability; (i)
- System testing: (ii)
- (iii) Instrument reliability;
- User-device interface performance: (iv)
- Workspace access testing; and (v)
- Performance testing with compatible devices. (vi)
Software verification, validation, and hazard analysis must be performed.
- (8) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
- (9) Performance data must demonstrate the sterility of all patient-contacting device components.
- (10) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
- (11) Performance data must validate the reprocessing instructions for the reusable components of the device.
- (12) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
- (13) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
- (14) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate
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such reporting, which comprises the following information:
- Cumulative summary, by year, of complaints and adverse events since date of (i) initial marketing authorization; and
- (ii) Identification and rationale for changes made to the device, labeling, or devicespecific use training program, which did not require submission of a premarket notification during the reporting period.
BENEFIT/RISK DETERMINATION
Risks
The risks of the device are based on data collected in the non-clinical and in vivo studies described above.
General risks of the Symani Surgical System include:
-
- Electromagnetic disturbances, electrical fault, mechanical fault, or system malfunction resulting in patient injury or a delay of treatment or patient harm. There was one device related adverse event resulting in tissue injury. The feature that contributed to this injury was removed from the device. There were device malfunctions that resulted in the surgeon converting to manual anastomoses. However, none of these events resulted in tissue injury with a minimal delay in treatment due to the device's fluid integration into and out of the workflow. The risks have been mitigated through bench, thermal safety, mechanical safety, electrical safety, electromagnetic compatibility, software testing, and labeling. These risks will also be mitigated through annual reporting.
-
- Use error resulting in patient harm such as tissue injury, thrombus formation, or reoperation is a risk. There was no thrombosis contributing to anastomosis failure. There was one reoperation to revise the anastomosis in the extremities (1/31; 3.23%) due to failure after the index free-flap procedure, however this rate is lower than literature [3]. This risk has been mitigated through human factors validation testing, in vivo testing, and labeling. This risk will also be mitigated through annual reporting.
-
- The device has shown to prolong the operation, which places the patient at higher risks to anesthetic treatment and medications. This risk has been mitigated through in vivo testing. These risks will also be mitigated through annual reporting.
The patient population (i.e., sample size, demographic, comorbidities) was a limitation with the in vivo study. The demographics and comorbid conditions between the in vivo study and the United States population are different. A postmarket study will be conducted evaluating safety (e.g., anastomosis-specific reoperation rate through 3 days) in a population representative of the general United States population in free-flap procedures of the breast and extermities.
Benefits
The probable benefits of the device are also based on the non-clinical and in vivo studies as described above.
Probable benefits of the Symani Surgical System include:
-
- The device's technology (i.e., motion scaling, tremor reduction) makes it an effective
33
surgical tool for the creation of micro-surgical vessel anastomoses. In the animal study the robotic intra-operative patency rate (100%) was similar to manual (100%). In the 28-day post-operative period, the robotic patency rate (100%) was greater than manual (93.8%). The vascular anastomosis patency rate at first attempt was 100% for the breast and 90.9% for the extremities in free-flap procedures. The lymphovenous anastomosis patency rate at first attempt was 96.7% for the upper extremities and 94.3% for the lower extremities in lymphatic surgery. All lymphovenous anastomoses were patent by the second attempt.
-
- The device improves the performance and accuracy of microvascular suturing. Both experienced microsurgeons and users with no microsurgery experience had improved needle angulation entrance accuracy during suturing. The cohort of users with no microsurgery experience demonstrated a statistically significant improvement compared to suturing manually in pre-clinical data.
-
- The device integrates into the workflow for microvascular anastomotic creation, with features that support patient safety and improve surgeon comfort and musculoskeletal pain. The use of the device takes seconds to minutes to move in-and-out of the operative field. supporting fluid integration into the normal surgical workflow. The hand controllers are used and held in a similar fashion to manual instruments, which allows for efficient transference between operative approaches. Also, the surgeon remains scrubbed by the bedside while utilizing their preferred compatible microscope, which supports patient safety and is evidenced similar 3-day reoperation rates compared to the literature comparator [3]. With the device's integration into workflow, the user can elect to place the stitches entirely robotically or with a combined robotic and manual hybrid-type application, depending on anatomic considerations and/or user preference. A qualitative survey of surgeons participating in a non-clinical study using artificial vessels showed greater satisfaction with the Symani surgical system versus conventional microsurgery, specifically, an improvement in back and neck tenderness and operative comfort [2]. This study also demonstrated that experienced mricosurgeons and users with no microsurgery experience showed a fast-learning curve with significant improvements in anastomotic creation times by the 5th anastomosis [2] ..
The in vivo studies did not evaluate long-term effectivness associated with creating a lymphovenous anastomosis in lymphatic procedures using the Symani Surgical System. Due to the risks being low for lymphatic surgery this will be evaluated in a postmarket study in a population representative of the general United States population. Additionally, while the nonclinical data demonstrated a fast-learning curve with Symani, the clincal data demonstrated that use of this device increased the suturing time compared to manual suturing in clinical use. This may put patients at a higher risk to anesthetic treatment and medications. To further mitigate this risk a postmarket study will also be conducted in all the procedures (i.e., free-flap procedures of breast and extremities and lymphatic procedures of the extremities) to determine the learning curve for novice and experienced surgeons evaluating robotic suturing proficiency with increased experience using the Symani Surgical System.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
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Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities.
The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the surgeon. The System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use
The probable benefits outweigh the probable risks for the Symani Surgical System. The device provides benefits, and the risks can be mitigated by the use of special controls.
Conclusion
The De Novo request for the Symani Surgical System is granted and the device is classified under the following:
Product Code: SAO Device Type: Electromechanical system for open microsurgery Regulation: 21 CFR 878.4963 Class: II
REFERENCES
-
- Ballestin A et al. New Robotic System with Wristed Microinstruments Allows Precise Reconstructive Microsurgery: Preclinical Study. Ann Surg Oncol. 2022; 29(12):7859-7867. doi: 10.1245/s10434-022-12033-x.
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- Wessel K.J. et al., Combined Application of a Novel Robotic System and Exoscope for Microsurgical Anastomoses: Preclinical Performance, Journal of Reconstructive Microsurgery Open. Nov 2023.
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- Arakelyan S. Aydogan E. Spindler N, Langer S, Bota O. A retrospective evaluation of 182 free flaps in extremity reconstruction and review of the literature. GMS Interdiscip Plast Reconstr Surg DGPW. 2022 Jan 14;11:Doc01. doi: 10.3205/iprs000162. PMID: 35111561; PMCID: PMC8779818.